1、Designation: F 1886 98 (Reapproved 2004)Standard Test Method forDetermining Integrity of Seals for Medical Packaging byVisual Inspection1This standard is issued under the fixed designation F 1886; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、 of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers the determination of channels inthe package seal down to a width of
3、 75 m (0.003 in.) with a60100 % probability (see Section 8).1.1.1 The ability to visually detect channel defects inpackage seals is highly dependent on the size of channel, thedegree of contrast from sealed and unsealed areas, the amountand type of adhesive between the two package layers, reflect-in
4、g light angle, types of material used, the use of magnification,and the inspectors level of training and experience.1.2 This test method is applicable to flexible and rigidpackages with at least one transparent side so that the seal areamay be clearly viewed.1.3 The values stated in SI units are to
5、be regarded as thestandard. The values given in parentheses are for informationonly.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and
6、 determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F17 Terminology Relating to Flexible Barrier Materials3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 channel, nany unimpaired pathway across the entirewidth of the
7、intended seal.3.1.2 sterile package integrity, nproperty of the packageseal and material, which ensures that it presents a microbialbarrier. (see also Terminology F17, microbiological packageintegrity).4. Summary of Test Method4.1 This test method provides a qualitative (accept/reject)visual inspect
8、ion method to evaluate the appearance character-istics of unopened, intact seals in order to determine thepresence of defects that may affect the integrity of the package.5. Significance and Use5.1 Seal attributes can be linked directly to a number ofvariables in process parameters, equipment, or ma
9、terial, as wellas environmental (room temperature and relative humidity).Visual seal characteristics and defects can provide evidence ofsterile package integrity and production sealing problems.5.2 Visual seal defects often will be the first indication ofheat sealing process variation. They also wil
10、l indicate a lack of,or potential compromise to, package integrity after physicalpackage performance testing.6. Apparatus6.1 Illuminant, lighting arrangements to give about 540lumens/m2(50 fc) of white light or daylight on the specimens.6.2 Indelible Marking Pen.7. Procedure7.1 Visual acuity shall b
11、e such that the inspection of the sealmay be performed at a distance of 30 to 45 cm (12 to 18 in.)NOTE 1Magnification devices, such as eyeloops, may be used as ananalytical tool to characterize identified seal defects.7.2 Inspect the entire sealed area of the package for com-pleteness and uniformity
12、.NOTE 2Different package sizes and shapes may require differinglengths of time to adequately inspect the entire seal perimeter. Any timerequirement associated with visual inspection should allow for completeseal inspection.1This test method is under the jurisdiction of ASTM Committee F02 on Flexible
13、Barrier Materials and is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved June 1, 2004. Published June 2004. Originallyapproved in 1998. Last previous edition approved in 1998 as F 1886 98.2For referenced ASTM standards, visit the ASTM website, www.astm.o
14、rg, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.NOTE 3Some p
15、ackaging materials and adhesives may fluoresce underultraviolet light. Viewing the seal area in a UV light box will enhance thesealed-to-unsealed area contrast, and provide for easier defect identifica-tion.7.3 Identify and record any part of the seal where channelsappear across the entire seal widt
16、h. Mark the location of thechannels.NOTE 4All other assessed defects (refer to Appendix X1) should becategorized according to user defined accept/reject criteria. Define theactions to be taken in the event defects are detected during normalproduction runs.7.4 Record the number and location of channe
17、ls identifiedon each package.NOTE 5If confirmation of channels or incomplete seal areas inpeelable packages is necessary, hand peel such suspected packagecompletely separating the two material components and inspect the sealarea of the transferred adhesive for the same incomplete seal attributes ast
18、he unopened package. Care should be taken to ensure a smoothcontinuous peeling motion so as not to cause any extraneous attributes.Heat seals should be cooled to ambient conditions before peeling open toallow for adhesive bonding to the opposite substrate to occur.In some instances, a channel or uns
19、ealed area may be observed onlyafter the package is peeled open. Adhesive transfer is a qualitativemeasure of a materials ability to release the coating rather than conclusiveevidence that the seal has not been made. It is possible to have continuousseal integrity but fail to give complete transfer.
20、 This is because the coatingmay have a stronger affinity for the substrate on which it is coated ratherthan the one to which it is sealed. In such cases, an additional physical sealintegrity test may be required to confirm if it is an unsealed area.8. Precision and Bias38.1 A round robin study was c
21、onducted in 1997, whichincluded ten laboratories, four package types, and two differentchannel sizes randomly produced with 75 m (0.003 in.) and125 m (0.005 in.) diameter wire. The negative control consistsof the same type packages produced with no channels. The fourdifferent types of medical device
22、 packages are:8.1.1 Open pouch (5 by 7 in.)clear film/coated paper;8.1.2 Open pouch (514 by 712 in.)clear film/uncoatedTYVEK4;8.1.3 Sealed rigid blister (812 by 514 in.)blue tintedblister/coated TYVEK; and,8.1.4 Open end pouch (6 by 812 in.)clear film/clear film(clear seal).8.2 The results of this s
23、tudy are pass or fail; therefore, thedata is binomial with an expected average of np and anexpected variance of npg where n is the number of samples, pis the probability of an incorrect evaluation, and q is theprobability of a correct evaluation. A statistical analysis of thedata by means of a conti
24、ngency table show significant differ-ences between all factors presented in the tables at a confidencelevel of better than 99 %. The results are presented in Tables1-4.9. Keywords9.1 channels; medical packaging; minimum seal width;spotty seals; sterile package integrity; visual seal inspection3Suppo
25、rting data have been filed at ASTM International Headquarters and maybe obtained by requesting Research Report RR: F021013.4TYVEK is a trademark of Dupont, Wilmington DE.TABLE 1 Percent Incorrect by LaboratoryLab SamplesInspectedIncorrectAnalysisPercent (%)Incorrect1 117 0 0.002 117 24 20.513 117 5
26、4.274 117 17 14.535 117 5 4.276 117 12 10.267 117 9 7.698 117 18 15.389 117 26 22.2210 117 10 8.55TABLE 2 Percent Incorrect by MaterialMaterialSamplesInspectedIncorrectAnalysisPercent (%)IncorrectFilm paper 300 14 4.67Film TYVEK 300 38 12.67PETG/TYVEK 290 59 20.34Film/film 280 15 5.36TABLE 3 Percent
27、 Incorrect by Defect TypeDefect TypeSamplesInspectedIncorrectAnalysisPercent(%) IncorrectNo channels 370 20 5.4175 m channel 400 83 20.75125 m channel 400 23 5.75TABLE 4 Percent Correct by Material and Defect TypeMaterial Defect TypeSamplesInspectedCorrectAnalysisPercent (%)CorrectFilm/paper none 10
28、0 97 9775 m 100 89 89125 m 100 100 100Film/TYVEK none 100 97 9775 m 100 69 69125 m 100 96 96PETG/TYVEK none 90 88 9875 m 100 60 60125 M 100 83 83Film/film none 80 68 8575 m 100 99 99125 m 100 98 98F 1886 98 (2004)2APPENDIX(Nonmandatory Information)X1. VISUAL SEAL APPEARANCE CHARACTERISTICS AND PROBA
29、BLE CAUSESX1.1 This appendix will serve to review some of thecommon seal appearance characteristics that may occur andsome common reasons for that occurrence. Specifications forthese seal characteristics need to be established by individualorganizations for their specific product and package styles.
30、Each requirement should be established with appropriaterationale and necessary supporting documentation.X1.2 Unsealed AreasAn unsealed area occurs when aheat seal is never made to the package or when a seal has beenmade to a package and is later ruptured. Causes to this probleminclude misalignment o
31、f package to seal bar or platen, mis-alignment of the seal bar or platen to the mating seal surface,foreign matter underneath the seal bar or platen preventing aseal, or damage to the seal bar or platen that prevents the seal.There also can be foreign contamination on the packagingmaterials that pre
32、vents a seal from being made. Seal rupturecan occur due to internal or external forces placed on the sealdue to sterilization conditions, weight of product, stressfulhandling of the package, and so forth. The visual characteris-tics of a package that has never been sealed versus one that hasbeen sea
33、led, and subsequently opened, are very different, anddepend on the material substrates being examined.X1.3 Nonhomogeneous or Undersealed AreasThis occurswhen a heat seal is made, and may not have adequate strengthdue to incorrect process parameters, such as temperature,pressure, or dwell. Insufficie
34、nt sealing temperature either toomuch, too little, or unevenly applied pressure; too short aprocess time; or, excessive material thickness variation aresome of the conditions that may cause seals to appear to bespotty or mottled. A spotty or mottled appearance may be afunction of the adhesive proper
35、ties, as well. This attribute maybe in varying degrees of severity and should be categorizedbased on appearance and whether sterile package integrity canbe maintained. Often it is easier to see this type of defect undera magnifying light or UV light box.X1.4 Oversealed AreasA combination of too much
36、 heat,pressure, or dwell time may cause oversealing to the point thatit may cause packaging components to melt and become brittleand susceptible to cracking. When TYVEK spunbonded poly-olefin or a similar porous material is one of the substrates, thiscondition often is seen as a transparent or trans
37、lucent sealwhere the material fibers are fused. This may become evidentthrough an evaluation for pinholes or cracks along the seal.Another result of oversealing may be a spotty or incompletelooking seal where, in this case, the heat seal adhesive isoverheated and flows into the porous fiber structur
38、e of thematerial.X1.5 Narrow SealsThis may occur either during thesealing process or as a result of seal creep or partial rupture ofthe seal due to environmental stresses. Misalignment of thepackage under the sealing die, skewed packaging components,bulging product, or misalignment of cutters/slitte
39、rs during thetrimming operation are a few causes that may occur during thesealing process. Seal creep may be a result of the sterilizationprocess or stressed seals at temperature extremes. Impact alsomay cause the seals to partially rupture. The width of packageseals need to be compared to individua
40、lly defined specificationlimits to ensure the package will maintain its integrity throughthe expected sterilization, handling, and distribution systems.X1.6 ChannelsThis is seen as an unsealed pathway acrossthe entire width of the intended seal. Causes for channels havebeen discussed above in X1.2.X
41、1.7 Wrinkles/Foldovers/CracksFoldovers occur when amaterial is folded over prior to the seal being formed. In somesituations the seal may be of adequate strength to form acomplete seal. In other situations there may not be adequatestrength, and a channel results. Wrinkles and cracks occur aftera sea
42、l is formed and are caused by the handling of the package.Generally, this occurs with flexible substrates. These too canresult in a channel through the entire seal. These types ofcharacteristics often are hard to judge by visual inspectionalone and need to be further evaluated by alternate means suc
43、has dye penetration.X1.8 Tears/PinholesThese typically occur within the ma-terial substrates, rather than the seal itself. Visual inspectionmay or may not detect tears or pinholes. Further evaluationmay be required if visual inspection is not adequate todetermine acceptability. Light box inspection
44、or physicalpackage integrity tests may be appropriate.F 1886 98 (2004)3ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of
45、any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are
46、 invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not rece
47、ived a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 1886 98 (2004)4
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